- Are you skilled and experienced in planning and documenting medical device activities, in all phases of the development process?
- Do you want to develop medical devices of the future, for top-tier Danish and international Med-Tech companies?
- Would you like to join an expert Design Control team, who works dedicatedly with our clients, to get new medical devices approved by the authorities?
- Do you thrive in a consultant role, in a high pace innovative environment?
Then join Technolution and become part of an energetic and innovative, rapidly growing company. We can assure you, that you will boost your professional experience and knowledge, while assisting our clients in successfully launching new medical devices.
In the job as Design Control Specialist, you will join our team of highly skilled experts in Design Control for medical devices. Your technical insight, combined with your medical development experience, will ensure the development of design control documentation at a correct and sufficient level, both in-house and at our clients.
In your daily work, you will bridge development, RA, and QA competencies at Technolution and our clients, while propelling Design Control activities.
The primary workplace will be in the Copenhagen area. You will be working in a fast-paced, collaborative environment where you will ensure project progress, and be working with our clients on specific projects. In this position, you will build strong bonds with your colleagues at Technolution through project collaboration, our weekly breakfast sessions, and regular social events. As a consultant at Technolution, you will also get a large network outside of Technolution.
Typical tasks for this position:
- Planning and implementing the Design Control documentation, including Risk Management, in compliance with current regulatory standards for medical device development
- Participate in integrating Risk Management and Usability Engineering activities
- Identification and analysis of risks and defining mitigations in collaboration with development teams
- Continuous improvement and optimization of Technolution’s Design Control procedures and templates, in collaboration with your colleagues
- Handle projects, including budgets and timelines
- Work with a wide range of highly skilled and capable colleagues and clients in different exciting, new device development projects
- Organize, prioritize and coordinate work activities with the ability to meet deadlines
- Continually develop your skillset to stay up to date
About your qualifications
- Good understanding of – and proven experience with Design Control, ISO 13485, ISO 14971, MDR, IEC 62366-1. Knowledge of FDA requirements for the development of medical devices is an advantage, but not a requirement.
- 3+ years of experience with product development, preferably in MedTech
- Hands-on design control experience, including the creation of requirements, test plans, test protocols, and test reports
- Hands-on risk management experience
- Proven ability to handle projects and work in a time-sensitive environment
- Relevant education on bachelor or master’s level, or relevant training
- Fluent in Danish and English
- You are not afraid of taking on a challenge, and you are flexible enough to know when you need to search for new paths to reach the target
- You are a bright and high-energy team member motivated to learn, collaborate, and contribute
- You take responsibility for actions, projects, people, and deadlines
- You are open-minded and a good communicator
- You have an analytical, structured, and systematical approach to solve problems
- You can work efficiently both in groups and alone
- You are good at giving and receiving feedback
- You are self-driven, but know when to ask for help and keep your team informed
- You demonstrate an understanding of how one issue may be a part of a much larger system – called ‘holistic thinking’
- You can communicate clearly and in a friendly but professional manner with both colleagues and clients
What you can expect from us
- Extensive contact with elite Danish and foreign MedTech companies, across industry segments and disciplines
- A unique chance of being part of a successful and fast-growing company
- An informal and trustful work environment where professionalism and friendliness are keywords and initiatives are welcomed and appreciated
- Plenty of possibilities to put your mark on exiting projects and our company culture
- Regular educational sessions on various relevant topics to keep everyone best in class
- Regular social events to get to know your colleagues
- Attractive salary, health care insurance, and the possibility to partake in the employee stock program
Technolution A/S is a growing consultancy company, assisting world-leading MedTech and Pharmaceutical companies in succeeding with developing innovative medical devices – from idea to launch. We work in compliance with ISO 13485/9001. Technolution has a flat organization with 45+ employees, spanning over 7 overall areas of competence (Mechanical Engineering, Test & Verification, Quality Management, Usability Engineering, UX & Design, Design Control, and Business Development).
We are proud of our collaborative and informal culture where social activities and the development of our professional skills are paramount. Technolution is a place where there is room for individuality, initiative, and where everyone is expected to take responsibility. The office in Hørsholm is located in beautiful surroundings and includes great facilities such as a prototyping workshop and a test lab.
Become a part of our specialist team – apply now!
Join our team of dedicated specialists at Technolution, on our fast and ambitious journey to becoming the leaders of our industry by making all our clients happy through fast-paced, high-quality innovation.
Do not hesitate to contact Head of Design Control Michael Tokeskov Mikkelsen if you have further questions about this position: + 45 70884220
You can also find more information about Technolution on our website or on LinkedIn.
Please send your application and CV to: firstname.lastname@example.org
We are looking at filling this position as fast as we can and will handle applications continuously. All applications are saved for 6 months and then deleted
This is where we live